Early identification and understanding of Critical Quality Attributes (CQAs) are essential steps in the process. From a QbD perspective, scientists, researchers, and regulators look for consistency, both in physical and chemical attributes. PTA is here to help you define, specify, and control the critical quality attributes of your materials. Backed by Micromeritics with 50+ years of instrumentation and application development used for solving real-life process and quality problems with pharmaceutical and biological products, Particle Testing Authority (PTA) is uniquely positioned to offer our customers expertise that is unrivalled by other contract analytical services laboratories.
Our Analyses Provide Solutions:
- Streamlining Pharmaceutical Development
- Preformulation Solutions
- Identification/Evaluation of API, Excipient, and Blended Material Critical Quality Attributes
- Excipient Screening
- Drug Carrier Pharmacokinetics
- Lab Services for Implementing QbD and PAT initiatives in line with ICH Q6A, Q8, Q9, and Q10 Guidelines
- Formulations and Drug Delivery
- Using Materials Science to Model and Predict Material Behavior
- Process Design and Pilot Scale-Up
- Characterization Solutions for Robust Quality Control
- Raw Material Qualification
- Assessment of Lot-to-Lot Variability
- Assistance in Quality Investigations and CAPAs
We also are DEA-licensed, FDA-registered, and cGMP-compliant.
USP <729> Globule Size Distribution of Lipid Injectable Emulsions
USP <788> Particulate Matter in Injections
USP <789> Particulate Matter in Ophthalmic Solutions
USP <429> Light Diffraction Measurement of Particle Size Ph. Eur. 2.9.31 Particle Size Analysis by Laser Light Diffraction JP 10 Laser Diffraction Measurement of Particle Size
USP <811> Powder Fineness
Surface Area (Gas Adsorption, BET)
USP <846> Specific Surface Ara Ph. Eur. 2.9.26 Specific Surface Area by Gas Adsorption JP 3.02 Specific Surface Area by Gas Adsorption
Density (True, Apparent, Bulk, TAP, Carr index)
USP <699> Density of S olids – Gas Pycnometry Ph. Eur. 2.2.42 Density of Solids JP 3.03 Powder Particle Density Determinations
Porosity (Gas Adsorption, Mercury Porosimetry)
USP <267> Porosimetry by Mercury Intrusion
Ph. Eur. 2.9.32 Porosity & Pore Size Distribution of Solids by Mercury Porosimetry
Powder Rheology and Flow Characterization
USP <1174> Powder Flow
Ph. Eur. 2.9.36 Powder Flow
Dynamic Vapor Sorption (DVS)
USP <1241> Water Solid Interaction in Pharmaceutical Systems
- System Stability by Zeta Potential or Particle Migration Kinetics
- Volumetric Vapor Sorption
- Surface Energy (IGC)
- Thermal Analysis (DSC and TGA)
Method Development / Validation
- Method Development Services
- Method Validation Services
- Method transfer documentation
- Secure Method and Validation storage for future projects
To determine which tests and analyses we can employ to meet your needs and to submit your samples, click here, or call 770-709-7112 to discuss your testing requirements.
Excipient Screening Services
With a full suite of physical characterization, thermal analysis, and surface energy analytical tools, PTA has the ability to provide you with the information necessary to make decisions based on current science and technology. Many customers have found tremendous cost savings in formulation development when using our services.
PTA Analyses Include:
- Particle size
- Particle Shape
- BET Specific Surface Area Density
- Surface Energy
- IGC (Inverse Gas Chromatography)
- DSC (Differential Scanning Calorimetry)
- MDSC (Modulated Differential Scanning Calorimetry)
Preformulation Services & Support
During this phase, research is directed to APIs and excipients, both as individual components and blends. Identification and evaluation through physical measurements include:
Formulation Support for Solid, Semi-Solid, and Liquid Forms
In QbD, this phase is focused on providing a defined design space to meet FDA and ICH guidelines. Within this area of focus, greater detail is developed for Critical Materials Attributes (CMA) and Critical Process Parameters (CPP).
Formulation and Blend Characterization
- API particles (Dry and Suspensions)
- Excipient Screening [same link as earlier]
- Lipid, Liposome, Polymer, and Polysaccharide drug delivery mechanisms
- Characterization of particulate morphology (surface characteristics) after micronization, milling, and grinding that may affect material performance.
Particle Testing Authority has a complete line of analytical tools to characterize your formulations. We specialize in wet and dry (roller compact) granulation characterization. New emphasis is being placed on characterization tools throughout the production process. From ribbon density and porosity to wet granulation density and porosity, PTA has the experience and analytical capability to provide you with the answers that you seek. We have helped numerous customers overcome processing problems that have been linked to the physical characteristics of the granulation form of a drug. Knowing the porosity and density at this step will help you to predict material movement and behavior throughout the process as well as behavior of the material on the press.
Process Design and Pilot Scale-Up
Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e. during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.